Good Manufacturing Practices - Compliance and Certification

http://www.nowfoods.com/Quality/Quality-Notes/M101282.htm

 

Good Manufacturing Practices - Compliance and Certification

 

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What are Good Manufacturing Practices (GMPs)? What is the difference between compliance and certification? What do the alphabet of names – cGMPs, NPA GMP, NSF GMP, USP GMP, ISO – mean, and how do they compare? Here are some answers.

Good Manufacturing Practices (GMPs) refer to establishing manufacturing procedures, documenting and following these procedures, the training of operators to follow these procedures, and processes for the investigation and corrective actions following deviations from these procedures. The purpose is to ensure the products are manufactured safely and that quality is assured.

For many products, GMPs are established by regulatory authority. For example in the U.S., pharmaceutical products, medical devices, and foods each have their own GMPs (called cGMPs – c is for current) that are established by the FDA. In addition, the FDA has recently established cGMPs for dietary supplements, and these are being phased in over three years, with a final completion date of December 2009.

The FDA expects manufacturers of dietary supplements to comply with cGMPs. The FDA does not certify companies to be in compliance with the cGMPs. Instead, when the FDA inspects a manufacturing facility, it will issue “observations” which in fact identifies deficiencies, whereby the manufacturer will need to correct these deficiencies. No certification is issued.

On the other hand, there are a number of independent bodies that will inspect manufacturers and certify compliance with GMPs. In the U.S., prior to the enactment of the FDA cGMPs, two certifying organizations were the Natural Products Association (NPA) and NSF International. Both these organizations had essentially the same standards for certification (in fact, contrary to popular belief, NSF licensed the GMP requirements from NPA). NSF allows a mark on the certified products, but NPA does not. NSF is a private company. NPA is an industry trade association. At present, since the FDA has issued the new dietary supplement cGMPs, and the cGMPs trump all other GMP programs, these organizations have in fact converted their GMP programs to at least meet, and I know that in the case of the NPA GMP program, exceed, the FDA cGMPs. So companies like NOW Foods can continue to be certified by the NPA, as we will thereby also comply with or exceed the FDA cGMPs.

USP (The United States Pharmacopeia) also has a GMP program. This program requires that ingredients be USP certified. This is typically the case for many amino acids, vitamins, and certain other highly purified ingredients, but does not cover all ingredients. If a product contains both USP and non-USP ingredients, then strictly speaking it does not meet the requirements of USP. This is the case with many dietary supplements. So be aware that when companies say their products are USP certified it may mean some or all of the ingredients might be, but the finished product they are used in might not be.

USP also has a verification program, and allows a verification mark to be used on products. This program includes testing of supplements. However, until and unless this program is changed to conform with the FDA cGMPs, it has limited value. Also it’s important to note that contrary to a common misperception, USP is not the U.S. official standards-setting body for dietary supplements.

ISO is a different ball of wax. ISO is a set of international standards that manufacturers of anything – pencils, chemicals, computers, foods, etc., to which companies may get certification, if they provide the required documentation. ISO certification is very general and not specific enough for dietary supplements, and does not cover some of the safety features associated with the FDA cGMPs. Contrary to some recent reports, ISO certification has little value for dietary supplements, again since the FDA cGMPs trump this certification. But companies that are ISO certified can use this mark on their products.

Since the FDA does not certify companies, companies will look to these third party certifiers to obtain certifications. The best are NPA and NSF, since their certifications meet or exceed the FDA cGMPs. NOW Foods is certified by NPA. Other certifying agencies, such as USP and ISO, are of less value for our industry because they do not cover all of the dietary supplement requirements in the FDA cGMPs. The marks that these agencies allow manufacturers to put on their products are nice, but are substandard today in terms of regulatory requirements.

So is this complicated? Yes! The best approach is to focus on the new gold standard, the FDA cGMPs, and look for certification by authoritative bodies such as NPA and NSF that inspect and certify companies as meeting or exceeding the federal cGMP requirements